Bio & Medicine

Alteogen to enter late-stage study of Herceptin biosimilar

[THE INVESTOR]Alteogen is accelerating the development of a biosimilar version of the world’s top breast cancer drug Herceptin to join two other Korean firms in challenging big pharma Roche.

The KOSDAQ-listed Korean firm plans to enter the final phase 3 clinical trials of its ALT-02, a copycat version of Roche’s drug, which boasts global sales of 7 trillion won (US$6.13 billion) a year. ALT-02 completed phase 1 studies in Canada last year and is preparing for the final trials before sales approval and commercialization.

Founded in 2008, Alteogen posted revenue of 6.8 billion won in 2016. It is a small drug maker without facilities for mass biosimilar production. To resolve the production issues, the firm forged a partnership with local pharmaceutical manufacturer Dong-A Socio Holdings and its affiliate DM Bio as suppliers of ALT-02 in the late-stage clinical trials. DM Bio has a plant with an annual capacity of 8,000 liters.

“We are currently in talks with DM Bio to discuss the production volume and timing of clinical development,” an official at Alteogen said. “We plan on starting the phase 3 clinical trials this year.”

Along with Alteogen, Samsung Bioepsis and Celltrion are also looking to enter the breast cancer biosimilar market as the US patent of Herceptin is set to expire in 2019. In Europe, the patent already lapsed in 2014.

In October 2016, Samsung Bioepis -- a collaboration between Samsung Biologics and Biogen -- filed for sales approval of its version of Herceptin, known as SB3, from the European Medicines Agency.

The company plans to seek US regulatory approval this year. Celltrion, which launched its first biosimilar Remsima, referencing Johnson & Johnson’s Remicade, is hot on its heels.

Celltrion filed for ENA marketing authorization for Herzuma, its biosimilar for Herceptin, while planning to file for US approval before June.

So far, no Herceptin biosimilar has been launched in the global market. Mylan and Biocon’s proposed candidate is expected to be commercialized soon.